UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042909
Receipt No. R000045389
Scientific Title Study on improvement of digestive tract environment by green tea catechin
Date of disclosure of the study information 2021/01/06
Last modified on 2021/01/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Examination on the effect of green tea catechin on improvement of digestive tract environment
Acronym Green tea catechin and environment of digestive tract
Scientific Title Study on improvement of digestive tract environment by green tea catechin
Scientific Title:Acronym Green tea catechin and environmental improvement in digestive tract
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A catechin intake test will be conducted in healthy subjects to analyze the oral bacterial flora, intestinal bacterial flora, and intestinal / urinary metabolites before and after catechin intake. From this study, we will clarify the effects of catechin on the digestive tract via human oral and intestinal bacteria.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To analyze the change of oral bacteria and fecal bacteria before and after catechin intake by 16S rRNA metagenomic analysis by Illumina Miseq.
Key secondary outcomes Bile acids and short-chain fatty acids in the stool before and after ingestion, and urinary metabolites are measured before and after catechin intake as metabolites of intestinal bacteria.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 "Catechin" powder (Sanphenon EGCg-OP: manufactured and sold as a supplement by Taiyo Kagaku) is used. The EGCg intake is set to 300 mg / day and the intake period is 4 weeks (28 days).
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
50 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1. An adult (regardless of gender) who can obtain a written consent to participate in the research from the person himself / herself.
2. Those who are between the ages of 50 and 70 at the time of obtaining consent (regardless of gender)
3. Those who can comply with the following lifestyle habits during the test period from one week before the start of the test
Do not consume green tea.
Do not consume many foods with high polyphenol content such as chocolate.
Do not take antibiotics.
Do not use mouthwash or mouthwash.
Refrain from taking probiotics (mainly yogurt).
Do not take natto.
Do not smoke
Do not take prebiotics (dietary fiber and oligosaccharide supplements).
Key exclusion criteria 1. Those who are treating diseases that affect the research results (dental and oral diseases, digestive diseases, etc.)
2. Those who have an extremely irregular diet
3. Those who drink a lot of green tea and alcohol on a daily basis
4. Those who habitually engage in strenuous exercise such as marathons
5. Currently, under the guidance of a doctor, those who are or will be doing exercise therapy / diet therapy
6. Serious heart disease [heart failure, myocardial infarction, myocarditis, etc.], liver disease [liver failure symptoms (fulminant hepatitis), liver cirrhosis, liver tumor], renal disease [nephrotic syndrome, renal failure (acute and chronic), urinary poisoning Disease, hydronephrotic syndrome], neurological disease, psychiatric disease, malignant tumor disease, etc., and those who have general condition problems
7. Those who have participated in other clinical trials within one month before obtaining consent or who plan to participate in other clinical trials during the trial period.
8. In addition, those who are judged by the investigator to be inappropriate for the study (the risk to the study subject may increase or sufficient data may not be obtained).
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Yuji
Middle name
Last name Naito
Organization Kyoto Prefectural University of Medicine
Division name Molecular Gastroenterology and Hepatology
Zip code 602-8566
Address 465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku, Kyoto Japan
TEL 075-251-5519
Email ynaito@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Yuji
Middle name
Last name Naito
Organization Kyoto Prefectural University of Medicine
Division name Molecular Gastroenterology and Hepatology
Zip code 602-8566
Address 465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku, Kyoto Japan
TEL 075-251-5519
Homepage URL
Email ynaito@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Taiyo Kagaku Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Laboratory of Animal Science, Setsunan University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto Prefectural University of Medicine, Ethnical Review Board
Address 465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku, Kyoto Japan
Tel 075-251-5337
Email rinri@koto.kpu-m.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 01 Month 06 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2020 Year 05 Month 13 Day
Date of IRB
2020 Year 05 Month 13 Day
Anticipated trial start date
2020 Year 05 Month 13 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1. Statistical analysis method
Metagenomic analysis is performed in bacterial flora analysis. As a specific analysis method, the next-generation sequencer (NGS) analysis of the V3-V4 region of the 16S rRNA gene was performed on the intestinal flora using the collected feces, and the phylum-genus level of various intestinal flora was performed. The analysis will be performed using a pipeline for NGS data analysis consisting of five bioinformatics programs containing USEARCH (Edgar, 2010), QIIME (Caporaso et al. 2010), PICRUSt (Langille et al. 2013), FishTaco (Manor and Borenstein, 2017), and Phylloseq(McMurdie and Holms, 2013).

2. Cancellation of clinical trials
2-1. Occurrence of adverse events
If the investigator determines that the subject's clinical research continuation is not appropriate due to the occurrence of adverse events, the subject's clinical research will be immediately discontinued. If the clinical study is discontinued, the investigator will evaluate the association with the study food, record it along with the reason for discontinuation, and promptly notify the subject.
2-2. Subject's offer
If the subject's request discontinues participation or continuation of clinical research regardless of whether or not it is related to clinical research, including the person's free will, accidental accident, or illness, the investigator will discontinue the clinical research of that subject. ..
2-3. Not eligible for clinical trials
If it is found that the subject is not eligible for this clinical study after the start of the clinical study, or if it is found that the necessary evaluations, observations, tests, etc. cannot be performed due to the convenience of the subject after the start of the clinical study. Immediately discontinue the subject's clinical study and promptly notify the subject.

Management information
Registered date
2021 Year 01 Month 05 Day
Last modified on
2021 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045389

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.